Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Auto flammability
Administrative data
- Endpoint:
- relative self-ignition temperature (solids)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 AUG 2022 TO 06 OCT 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.16 (Relative Self-Ignition Temperature for Solids)
- Version / remarks:
- November 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-[(1-[[6-cyano-5-(trifluoromethyl)pyridin-3-yl]carbamoyl]cyclobutyl)amino]-2-fluoro-N-methylbenzamide
- Cas Number:
- 1950587-20-8
- Molecular formula:
- C20H17F4N5O2
- IUPAC Name:
- 4-[(1-[[6-cyano-5-(trifluoromethyl)pyridin-3-yl]carbamoyl]cyclobutyl)amino]-2-fluoro-N-methylbenzamide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch number of test material: 22CN0611
- Expiry date: 11 May 2023 (retest date)
- Purity test date: 31 May 2022 (certificate of analysis release date)
- Physical Description: Brown powder
- Purity: 99.9%
- Purity correction factor: no correction factor required
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
Results and discussion
Relative self-ignition temperature (solids)
- Key result
- Remarks on result:
- no self-ignition observed up to the melting point
Any other information on results incl. tables
No endothermic or exothermic effect of the test material was observed between 20°C and 240.8°C (i.e., the melting temperature of the test material; see point 4.2). It demonstrated that the test material is not self-ignitable.
After the experiment, the test material had turned into a brown/black residue and was collected in a container that was placed below the cube. It indicated that the test material had melted, decomposed and/or reacted during the experiment.
Applicant's summary and conclusion
- Conclusions:
- The self-ignition temperature of JNJ-63632335-AAA (T003671) was determined using a temperature programmed laboratory oven, a stainless steel wire mesh cube, NiCr/NiAl thermocouples and a temperature recording device.
Based on the results obtained the test material is considered ‘not self-ignitable’.
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